Uses

What is Primolut N® (norethisterone) used for?

Primolut N® is used for treatment of menstruation and disturbances of the monthly bleeding (dysfunctional bleeding), lack of the monthly bleeding (primary and secondary amenorrhea), premenstrual complaints (premenstrual syndrome).

How should I take Primolut N® (norethisterone)?

Always take norethisterone tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets with water.

This medicine should be taken for as long as your doctor tells you. If you finish the course, you will usually have a menstrual bleed 2-3 days after the last tablet. If you do not have a period, you must make sure you are not pregnant before taking more.

How do I store Primolut N® (norethisterone)?

Primolut N® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Primolut N® in the bathroom or the freezer. There may be different brands of Primolut N® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Primolut N® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Primolut N® (norethisterone)?

Primolut N® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Cytochrome P450 hepatic enzymes are those enzymes of concern, which may be affected by drug interaction resulting in either induction or inhibition of drug metabolism.

Does food or alcohol interact with Primolut N® (norethisterone)?

Primolut N® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Primolut N® (norethisterone)?

Primolut N® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Primolut N® (norethisterone).

What is the dose of Primolut N® (norethisterone) for an adult?

Metropathia haemorrhagica (dysfunctional uterine bleeding)

The recommended dose is 5mg three times daily for ten days. Bleeding is arrested usually within one to three days.

A withdrawal bleeding resembling normal menstruation occurs within two to four days after discontinuing treatment.

Pre-menstrual syndrome (including pre-menstrual mastalgia)

The recommended dose is 10 – 15mg daily from the 19th to the 26th day of the cycle.

Treatment should be repeated for several cycles. When treatment is stopped, the patient may remain symptom free for a number of months.

Postponement of menstruation

The recommended dose is 5mg three times daily, starting three days before the expected onset of menstruation. A normal period should occur two to three days after the patient has stopped taking tablets.

Dysmenorrhea

The recommended dose is 5mg three times daily for 20 days, starting on the fifth day of the cycle (the first day of menstruation counting as day one).

Treatment should be maintained for three to four cycles followed by treatment-free cycles. A further course of therapy may be employed if symptoms return.

Endometriosis (pseudo-pregnancy therapy)

The recommended dose is on the fifth day of the cycle with 10mg daily for the first few weeks.

In the event of spotting, the dosage is increased to 20mg and, if necessary, 25mg daily.

After bleeding has ceased, the initial dose is usually sufficient.

Duration of treatment is four to six months continuously, or longer if necessary.

Menorrhagia (hypermenorrhoea)

The recommended dose is 5mg two to three times a day from the 19th to the 26th day of the cycle (counting the first day of menstruation as day one).

What is the dose of Primolut N® (norethisterone) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Primolut N® (norethisterone) available?

Primolut N® is available in the following dosage forms and strengths:

Tablets 5mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Primolut N®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.